(158 days)
No reference devices were used in this notification.
No
The description focuses on the physical components, energy delivery, and temperature control of the device, with no mention of AI or ML algorithms for analysis, decision-making, or control.
Yes
The device is indicated for the treatment of pulmonary embolism through the infusion of physician-specified fluids, including thrombolytics, directly into the vasculature.
No
The device is described as an "Endovascular Device" for the "infusion of physician-specified fluids," indicating a therapeutic rather than diagnostic function. It is used to deliver treatment, not to identify or characterize a disease.
No
The device description clearly outlines hardware components including a disposable infusion catheter, ultrasound core with elements, thermal sensors, and a Control System that generates and controls radiofrequency energy. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The EKOS PE Endovascular Device is used to infuse fluids directly into the vasculature within the body. It is an interventional device used for treatment, not for performing diagnostic tests on samples.
- Intended Use: The intended use clearly states "infusion of physician-specified fluids... into the vasculature for the treatment of pulmonary embolism" and "infusion of solutions into the pulmonary arteries." This describes a therapeutic intervention, not a diagnostic test.
- Device Description: The description details a catheter and ultrasound core designed for delivering substances and applying energy within the body.
Therefore, the EKOS PE Endovascular Device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EKOS PE Endovascular Device with CU 4.0 is indicated for the:
- · Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- · Infusion of solutions into the pulmonary arteries.
- · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes
QEY, KRA
Device Description
The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, pulmonary arteries, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device.
| Product Specification | Purpose | EKOS PE Endovascular Device (Subject Device) | |
|---|---|---|---|
| T = 0 | Accelerated Aged (T=3 Years) | ||
| Physical Dimensions | Verified dimensional compatibility and stability with the MSD and DDC. | Pass | Pass |
| Tip Shape | Verified tip conformity to ISO 10555-1 requirements. | Pass | Pass |
| Kink Resistance | Verified device can be used within the target vasculature. | Pass | Pass |
| Tensile Strength | Verified device conformity to ISO 10555-1 requirements. | Pass | Pass |
| Electrical Safety | Verified device conformity IEC 60601-1 and IEC 60601-1-2 requirements. | Pass | Pass |
| Acoustic Characteristics | Verified device met specified acoustic design requirements. | Pass | Pass |
| Radiopacity | Verified device can be viewed under standard imaging techniques. | Pass | Pass |
| Pressure Resistance | Verified device lumens conformity to ISO 10555-1. | Pass | Pass |
| Temperature Sensing | Verified the device temperature sensors met specified design and functional requirements. | Pass | Pass |
| Functional Life | Verified device met specified functional life requirements. | Pass | Pass |
| Biocompatibility | Verified the device met biocompatibility requirements per ISO 10993-1. | Pass | Pass |
| Sterilization | Verified the device met sterilization requirements per ISO 11135. | Pass | Pass |
| Shelf Life | Verified the device met functional requirements after a 3-year shelf life. | N/A. | Pass |
| System Integration with CU4.0 | Verified the device integrates with the control unit, specifically, its acoustic protocol and enabled temperature safety features | Pass | N/A. |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this notification.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
August 17, 2020
EKOS Corporation Mr. Joshua Kim Sr. Regulatory Affairs Specialist 11911 North Creek Parkway S Bothell, Washington 98011
Re: K200648
Trade/Device Name: EKOS PE Endovascular Device with Control System 4.0 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: July 17, 2020 Received: July 20, 2020
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200648
Device Name
EKOS PE Endovascular Device with Control Unit 4.0
Indications for Use (Describe)
The EKOS PE Endovascular Device with CU 4.0 is indicated for the:
- · Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- · Infusion of solutions into the pulmonary arteries.
- · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Premarket Notification 510(k) Summary for K200648
l. Submitter
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Phone: 425-415-3114 Fax: 425-415-3105
Contact Person: Joshua Kim Date Prepared: August 17, 2020
ll. Device
| Proprietary Name: | EKOS™ PE Endovascular Device with CU4.0 | | EKOS PE Endovascular Device
with CU4.0
(Subject Device) | EkoSonic Endovascular Device
with CU4.0
(Predicate Device) |
|--------------------------------|-----------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Continuous Flush Catheter | 510(k) Number | K200648 | K183361 |
| Primary Classification Name: | Mechanical Thrombolysis Catheter (21 CFR §870.5150) | Product Code | QEY, KRA | KRA |
| Primary Product Code: | QEY | Indications for
Use | The EKOS PE Endovascular
System [with CU4.0] is indicated
for the:
• Ultrasound facilitated,
controlled and selective
infusion of physician-specified
fluids, including
thrombolytics, into the
vasculature for the treatment
of pulmonary embolism.
• Infusion of solutions into the
pulmonary arteries.
• Controlled and selective
infusion of physician-specified
fluids, including
thrombolytics, into the
peripheral vasculature. | The EkoSonic Endovascular
Device with CU4.0 is indicated
for the:
• Ultrasound facilitated,
controlled and selective
infusion of physician-specified
fluids, including thrombolytics,
into the vasculature for the
treatment of pulmonary
embolism.
• Infusion of solutions into the
pulmonary arteries.
• Controlled and selective
infusion of physician-specified
fluids, including thrombolytics,
into the peripheral
vasculature. |
| FDA Panel/Device Class: | Cardiovascular; Class II | Principle of
Operation | The EKOS PE Endovascular
System [EKOS PE Endovascular
Device with CU4.0] employs
ultrasound to facilitate the
delivery of thrombolytic agents
into vascular blood clots. | The EkoSonic Endovascular
System employs ultrasound to
facilitate the delivery of
thrombolytic agents into
vascular blood clots. |
| Secondary Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) | Infusion Hole
Pattern | Multiple side-holes | Multiple side-holes |
| Secondary Product Code: | KRA | Catheter
Working Length | 106 cm or 135 cm | 106 cm or 135 cm |
| FDA Panel/Device Class: | Cardiovascular; Class II | Treatment
Zone Length | 8 cm - 20 cm | 6 cm - 50 cm |
lll. Predicate Devices
The EKOS PE Endovascular Device with CU4.0 is substantially equivalent to another legally marketed device. This predicate device is the EkoSonic Endovascular Device with CU4.0 (K183361).
No reference devices were used in this notification.
IV. Device Description
The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
4
V. Intended Use/Indications for use
The EKOS PE Endovascular System is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, . including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- . Infusion of solutions into the pulmonary arteries.
- . Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
VI. Comparison of Technological Characteristics with the Predicate Device
5
E K.O)S)
| | EKOS PE Endovascular Device
with CU4.0
(Subject Device) | EkoSonic Endovascular Device
with CU4.0
(Predicate Device) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Compatible
Guide Wire | 0.035" | 0.035" |
| Outer Diameter | 7.7 Fr | 5.4 Fr |
| Placement
Mode | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged
Sterile | Yes - EKOS PE Endovascular
Device | Yes - EkoSonic Endovascular
Device |
| Single-Use
Disposable | Yes - EKOS PE Endovascular
Device | Yes - EkoSonic Endovascular
Device |
| Materials
Biocompatible | Yes – EKOS PE Endovascular
Device | Yes - EkoSonic Endovsacular
Device |
| Radiopaque
Markers | Yes on IDDC
MSD ultrasound elements are
radiopaque | Yes on IDDC
MSD ultrasound elements are
radiopaque |
| Mechanism of
Action | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU converted
to ultrasound | R/F electrical from CU converted
to ultrasound |
| Ultrasound
Transducer(s)
in Catheter | 8 to 20 | 6 to 30 |
| Acoustic
Characteristics | Frequency = 1.58-2.00 MHz | Frequency = 2.05 - 2.35 MHz |
| Maximum
Output Power
Limit | Power is available for ~100W
Pulses. The power output is
limited by software to ~50W. | Power is available for ~100W
Pulses. The power output is
limited by software to ~50W. |
| Maximum
EkoSonic
Device
Temperature | Temperature monitoring,
feedback and control system
limits the surface temperature of
the IDDC to 43°C during
operation | Temperature monitoring,
feedback and control system
limits the surface temperature of
the IDDC to 43°C during
operation |
The device modifications described in the notification do not affect the intended use, indications for use, or the technological characteristics for the EKOS PE Endovascular System (EKOS PE Endovascular Device with CU4.0).
6
VII. Performance Data
Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device.
| Product
Specification | Purpose | EKOS PE Endovascular Device
(Subject Device) | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------|
| | | T = 0 | Accelerated Aged
(T=3 Years) |
| Physical
Dimensions | Verified dimensional compatibility and stability
with the MSD and DDC. | Pass | Pass |
| Tip Shape | Verified tip conformity to ISO 10555-1
requirements. | Pass | Pass |
| Kink Resistance | Verified device can be used within the target
vasculature. | Pass | Pass |
| Tensile Strength | Verified device conformity to ISO 10555-1
requirements. | Pass | Pass |
| Electrical Safety | Verified device conformity IEC 60601-1 and IEC
60601-1-2 requirements. | Pass | Pass |
| Acoustic
Characteristics | Verified device met specified acoustic design
requirements. | Pass | Pass |
| Radiopacity | Verified device can be viewed under standard
imaging techniques. | Pass | Pass |
| Pressure
Resistance | Verified device lumens conformity to ISO 10555-
-
| Pass | Pass |
| Temperature
Sensing | Verified the device temperature sensors met
specified design and functional requirements. | Pass | Pass |
| Functional Life | Verified device met specified functional life
requirements. | Pass | Pass |
| Biocompatibility | Verified the device met biocompatibility
requirements per ISO 10993-1. | Pass | Pass |
| Sterilization | Verified the device met sterilization
requirements per ISO 11135. | Pass | Pass |
| Shelf Life | Verified the device met functional requirements
after a 3-year shelf life. | N/A. | Pass |
| System
Integration with
CU4.0 | Verified the device integrates with the control
unit, specifically, its acoustic protocol and
enabled temperature safety features | Pass | N/A. |
Table 1: Testing Overview Supporting the EKOS PE Endovascular System
Performance standards have not been promulgated for Mechanical Thrombolysis or Continuous Flush Catheters.
VIII. Conclusions
The EKOS PE Endovascular Device with CU4.0 is substantially equivalent to the predicate devices. The modifications to the EkoSonic Endovascular Device with CU4.0 do not affect the intended use or the technological characteristics for the system.